Risk Management Procedures Bundle | ISO 13485 | FDA QSR Compliant
SKU:
RISK-CB
$499.00
$499.00
The Risk Management Procedure Bundle includes four (4) EN ISO 14971:2012 compliant standard operating procedures relating to the risk management process for medical devices.
- EN ISO 14971:2012 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Includes Related Forms
- MS Word and Excel Format
- Digital Content - Instant Download
ISO 14971 Risk Management Procedure BundleThe Risk Management Procedure Bundle includes everything you need to establish sound risk management practices for your company. The bundle includes four (4) EN ISO 14971:2012, ISO 13485:2016 and FDA QSR compliant risk management procedures encapsulating the risk management process from product development through post-market feedback.
Risk Management Procedure Bundle - ContentThe Risk Management Procedure Bundle includes the following risk management related procedures:
Risk Management ProcedureThe Risk Management Procedure serves as the top level procedure governing design and production risk management, development of risk management plans, reports, and risk management files. The procedure includes a defined risk management flow, risk estimation tables, a 5x5 Product Risk Matrix, and detailed instruction on the development of Risk Management Files, Risk Management Plans and Risk Management Reports. The procedure includes multiple forms complete with helpful instruction. The procedure complies with EN ISO 14971:2012.
Design Risk Management ProcedureThe Design Risk Management Procedure provides detailed step by step guidance to help design teams properly identify design risks associated with the development of a medical device. The procedure includes multiple forms to capture the entire process in Excel format. The procedure complies with EN ISO 14971:2012.
Process Risk Management ProcedureThe Process Risk Management Procedure provides detailed step by step guidance to help design teams properly identify process risks associated with the production of a medical device. The procedure includes multiple forms to capture the entire process in Excel format. The procedure complies with EN ISO 14971:2012.
Design Analysis ProcedureThe Design Analysis Procedure includes detailed guidance on how to conduct DFMECA, PFMECA, House of Quality(HOQ) and Fault Tree Analysis(FTA). The procedure includes all related forms and ground rules for each study, The procedure complies with EN ISO 14971:2012.
Risk Management Procedures ComplianceThe Risk Management Procedures comply with the requirements of ISO 14971:2012, ISO 13485:2016, and FDA 21 CFR Part 820.
For more information about our Risk Management Procedure Bundle contact us at info@aplyon.com
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Risk Management Bundle Contents
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Risk Management Procedure
$149.00
The EN ISO 14971:2012 compliant Risk Management Procedure defines the process for the management of risks for medical products in their design, manufacture, and use to ensure they are safe and effective for their intended use.
- EN ISO 14971:2012 Compliant
- FDA QSR Compliant
- ISO 13485:2016 Compliant
- MDR EU 2017/745 Compliant
- Includes Related Forms
- MS Word and Excel Format
- Digital Content - Instant Download
Design Risk Management Procedure
$149.00
The ISO 14971 Design Risk Management Procedure focuses on design elements of the risk management process. The design risk management procedure is aligned with the requirements of ISO 14971:2012.
- EN ISO 14971:2012 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR (EU) 2017/745 Compliant
- Includes Related Forms
- MS Word and Excel Format
- Digital Content - Instant Download
Process Risk Management Procedure
$149.00
The ISO 14971 Process Risk Management Procedure governs production related risks. The ISO 14971 Process Risk Management Procedure is made part of the overall medical device risk management system.
- EN ISO 14971:2012 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word and Excel Formats
- Digital Content - Instant Download